News Follow-on Biologic Partnerships Grow in India President's Budget Allocates More Funding to FDA
EMA Releases New Guidance on Stem Cell Products
Catalent Pharma Solutions, a provider of development, technology, and manufacturing services, entered into a license agreement with the development company Pantec for the exclusive worldwide development rights to the Lyopan fast-dissolve technology for healthcare products. Biopharmaceutical company Cephalon formed an agreement with Alba Therapeutics, also a biopharmaceutical company, to purchase all of the assets relating to larazotide acetate, a tight-junction modulator progressing toward a Phase IIb clinical trial for the treatment of celiac disease. Cephalon will pay Alba a $7-million upfront option payment and will provide a credit facility to fund Alba's Phase IIb clinical trial expenses for larazotide acetate. Cephalon may exercise its option at any time prior to the expiration of a specified period after receipt of the final study report for the Phase IIb clinical trial. If Cephalon exercises its option, the company will purchase Alba's assets for $15 million. Alba could receive additional payments related to regulatory and sales milestones.
Nuron Biotech selected the Merck BioManufacturing Network, Merck’s contract manufacturing division, in the UK to manufacture large-scale GMP clinical supplies of NU100 and undertake process validation leading to long-term commercial operations. NU100 is a proprietary recombinant human interferon beta compound being developed for the treatment of multiple sclerosis. Nuron Biotech plans to take NU100 into Phase III clinical trials in 2011. Eli Lilly and the Juvenile Diabetes Research Foundation (JDRF) have signed an agreement to fund early-stage research that could enable patients with Type 1 diabetes to regenerate insulin-producing cells destroyed by the disease. The JDRF-Lilly agreement will support a three-year, $1.4-million preclinical research effort.
The global head of technical operations at Novartis talks about new technologies for vaccine development and manufacturing. See full story Safety concerns remain for developing replicating vectors based on the pathogen human immunodeficiency virus type 1. See full story
The World Health Organization (WHO) reported it will begin accepting shipments of Crucell’s Quinvaxempentavalent vaccine from its Shingal, South Korea, manufacturing facility. WHO concluded its investigation of Crucell’s temporary hold on shipments of the vaccine last October after the company suspected sterility problems, and WHO said in a press statement that it is “assured that the problems identified in 2010 have been resolved.” Shipments are expected to resume this month. Dalton Pharma Services, a pharmaceutical services provider, entered into a supply contract with Oncovir, a specialty-pharmaceutical company, to provide active pharmaceutical ingredient manufacturing and aseptic fill/finish services under current GMP. The agreement covers products for Oncovir’s collaboration with the Cancer Vaccine Acceleration Fund, a joint initiative between the Cancer Research Institute and the Ludwig Institute for Cancer Research. Merck’s Gardasil Approved to Prevent Anal Cancer
In the February Issue of BioPharm International An Economic Comparison of Three Cell Culture Techniques Achieving Process Intensification by Scheduling and Debottlenecking Biotech Processes The Powerful Lesson of the GSK–Whistleblower Case
FindPharma Careers Formulation Scientist/Sr. Formulation Scientist Formulation Chemist For more job listings, visit FindPharma Careers Industry Events March 1-3: Vaccine World Summitt March 9-10: PDA/FDA Atypical Actives Workshop March 14-16: BIO-Europe Spring 2011 - 5th International Partnering Conference March 26: Professional Development Short Course |
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